BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    MDR report key: 7191380 · Received January 15, 2018

    Report

    Report Number
    2939274-2018-50267
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 19, 2017
    Report Date
    December 19, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982190604
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NO.: 323.034, LOT NO.: L211199: MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: 01.DEC.2016: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2017, SURGEON WAS UNABLE TO THREAD THE 1.5MM THREADED DRILL GUIDE INTO THE PLATE. ANOTHER LOCKING GUIDE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED DELAY OR CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM THREADED DRILL GUIDE WITH DEPTH GAGE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33701 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE GUIDE FZX WRIGHTS LANE : SYNTHES USA PRODUCTS LLC L211199 10886982190604

    Patients

    Seq Age Sex Outcome Treatment
    1